Frequency of adverse events in landmark studies of currently approved BTKis
| Adverse events . | Ibrutinib . | Acalabrutinib . | ||
|---|---|---|---|---|
| RESONATE25 . | RESONATE83,84 . | ELEVATE-TN10 . | ASCEND12 . | |
| TN n = 135 . | RR n = 195 . | TN n = 179 . | RR n = 154 . | |
| f/u = 18.4 mo . | f/u = 19 mo . | f/u = 28.3 mo . | f/u = 22 mo . | |
| Atrial fibrillation | ||||
| All grades | 14 (10) | 13 (7) | 7 (3.6) | 9 (6) |
| Grade ≥ 3 | 6 (4) | 7 (4) | NR | 2 (1) |
| Bleeding | ||||
| All grades | 9 (7) | NR | 70 (39) | 44 (29) |
| Grade ≥ 3 | 8 (6) | 4 (2) | 4 (2) | 4 (3) |
| Hypertension | ||||
| All grades | 18 (14) | NR | 9 (5) | 7 (5) |
| Grade ≥ 3 | 5 (4) | 8 (4) | 4 (2) | 4 (3) |
| Arthralgia | ||||
| All grades | 27 (20) | 36 (19) | 28 (16) | 23 (15)* |
| Grade ≥3 | 3 (2) | NR | 1 (0.6) | 2 (1)* |
| Infection | ||||
| All grades | NR | NR | 116 (65) | 97 (63) |
| Grade ≥3 | 21 (23) | 59 (30) | 25 (14) | 30 (20) |
| Diarrhea | ||||
| All grades | 57 (42) | 105 (54) | 62 (35) | 30 (20) |
| Grade ≥3 | 5 (4) | 9 (5) | 1 (0.6) | 3 (2) |
| Adverse events . | Ibrutinib . | Acalabrutinib . | ||
|---|---|---|---|---|
| RESONATE25 . | RESONATE83,84 . | ELEVATE-TN10 . | ASCEND12 . | |
| TN n = 135 . | RR n = 195 . | TN n = 179 . | RR n = 154 . | |
| f/u = 18.4 mo . | f/u = 19 mo . | f/u = 28.3 mo . | f/u = 22 mo . | |
| Atrial fibrillation | ||||
| All grades | 14 (10) | 13 (7) | 7 (3.6) | 9 (6) |
| Grade ≥ 3 | 6 (4) | 7 (4) | NR | 2 (1) |
| Bleeding | ||||
| All grades | 9 (7) | NR | 70 (39) | 44 (29) |
| Grade ≥ 3 | 8 (6) | 4 (2) | 4 (2) | 4 (3) |
| Hypertension | ||||
| All grades | 18 (14) | NR | 9 (5) | 7 (5) |
| Grade ≥ 3 | 5 (4) | 8 (4) | 4 (2) | 4 (3) |
| Arthralgia | ||||
| All grades | 27 (20) | 36 (19) | 28 (16) | 23 (15)* |
| Grade ≥3 | 3 (2) | NR | 1 (0.6) | 2 (1)* |
| Infection | ||||
| All grades | NR | NR | 116 (65) | 97 (63) |
| Grade ≥3 | 21 (23) | 59 (30) | 25 (14) | 30 (20) |
| Diarrhea | ||||
| All grades | 57 (42) | 105 (54) | 62 (35) | 30 (20) |
| Grade ≥3 | 5 (4) | 9 (5) | 1 (0.6) | 3 (2) |
f/u, follow-up; NR, not reported in original publication; RR, relapsed or refractory; TN, treatment-naive.
Reported numbers reflect 16.1-month follow-up.85